Biologics

BIO Urges Tougher Standards for Repackaging Biologics

Biotechnology Innovation Organization (BIO) has urged FDA to state explicitly in a planned final guidance on “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application” that repackaged biological products should satisfy the same sterility requirements in place for products manufactured under approved BLAs. In comments on the draft guidance, the group notes that Congress recently reiterated the importance of close FDA inspection and supervision of large-scale compounding and repackaging of sterile injectable drugs and biological products to ensure that they are processed in keeping with current good manufacturing practice for sterile products. “Robust FDA enforcement of these requirements is essential to preventing future patient injuries,” it says.

BIO says it is concerned that the current draft guidance “fails to address the potentially dangerous standard practices currently being utilized by many compounding facilities, where repackaged biological products are often filled into syringes under conditions that do not meet ISO clean room standards and using procedures that have not been validated to ensure they effectively prevent contamination of the container and its contents. The pre-filled syringes are typically placed in common plastic bags for shipment. Such containers and secondary packaging are neither sterilized nor packaged under aseptic, carefully-monitored conditions needed to ensure the sterility of the container and the ability of the secondary packaging to remain sterile during shipment.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome